About this trial

This is a multicenter, prospective diagnostic accuracy study evaluating the Istanbul PSMA PET/CT Criteria (IPPC) for selecting patients with biopsy-confirmed low-risk prostate cancer (ISUP Grade 1) for active surveillance (AS). The study integrates delayed Ga-68 PSMA PET/CT imaging into the diagnostic pathway to refine patient stratification, minimize overtreatment and potentially reduce unnecessary biopsies and MRI, or exposing high-risk individuals to the danger of cancer progression if left untreated scans.

Eligibility criteria

Qualifiers

mpMRI performed within 3 months prior to enrollment

Systematic or MRI-targeted prostate biopsy performed

Biopsy-confirmed ISUP Grade 1 low-risk PCa

Prostate biopsy report specifying tumor localization and number of positive cores

Disqualifiers

High-risk or unfavorable intermediate-risk PCa, or adverse histologies (neuroendocrine, ductal adenocarcinoma, basal cell carcinoma, TP53 or BRCA1/2 mutations if available)

Prior prostate cancer treatment or prostate surgery

MRI evidence of extracapsular extension, seminal vesicle invasion, or nodal metastasis

History of pelvic radiotherapy

Trial design

Treatments tested in this trial

  • Ga-68 PSMA11 PET/CT

Treatment groups

No treatment groups listed

Locations

10
Yeditepe University34000, IstanbulTurkey, Turkey (Türkiye)
Bilkent Şehir Hastanesi Ankara Turkey (Türkiye)
Gazi Yaşargil Egitim ve Arastirma Hastanesi Diyarbakır Turkey (Türkiye)
Gaziantep Üniversitesi Şahinbey Araştırma ve Uygulama hastanesi Gaziantep Turkey (Türkiye)

Sponsors and collaborators

Istanbul University - Cerrahpasa

Lead sponsor

Yeditepe University

Collaborator

Yedikule Training and Research Hospital

Collaborator

Acibadem University

Collaborator

Ankara Yildirim Beyazıt University

Collaborator

University of Gaziantep

Collaborator

Istanbul Training and Research Hospital

Collaborator

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Collaborator

Sisli Hamidiye Etfal Training and Research Hospital

Collaborator

Haseki Training and Research Hospital

Collaborator